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In a four-page article published in the Journal of Mobile Technology in Medicine, William Garvin, counsel with Buchanan Ingersoll & Rooney, explains the regulatory uncertainty surrounding mobile medical apps.

“The main regulatory issue facing many mobile medical apps is whether these programs would be regulated as medical devices,” Garvin writes. “Under FDA law, medical devices face a variety of regulatory and procedural hurdles in order to be sold.”

Read the full article – “The Legal Perspective of mHealth in the United States,” (December 31, 2012)

Garvin’s article provides an overview of the current regulatory regime for mobile medical apps under FDA law and regulations, and provides a brief update regarding recent action that could have an effect on the mobile medical apps market.